[Federal Register Volume 71, Number 241 (Friday, December 15, 2006)]
[Notices]
[Pages 75554-75555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21317]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0037]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Proposed Experimental 
Study of Trans Fat Claims on Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January 
16, 2007.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Proposed Experimental Study of Trans Fat Claims on Foods--(OMB Control 
Number 0910-0533--Reinstatement)

    FDA is requesting OMB approval of a proposed experimental study of 
trans fat claims on food products intended to help FDA's Center for 
Food Safety and Applied Nutrition formulate decisions and policies 
affecting labeling requirements for trans fat claims on foods.
    In the Federal Register of July 11, 2003 (68 FR 41507), FDA issued 
an advance notice of proposed rulemaking entitled ``Food Labeling: 
Trans Fatty Acids in Nutrition Labeling; Consumer Research to Consider 
Nutrient Content and Health Claims and Possible Footnote or Disclosure 
Statements,'' which requested comments about possible disclosure 
requirements to accompany nutrient content claims about trans fatty 
acids that could help consumers make heart-healthy food choices. The 
proposed experimental study will evaluate the ability of several such 
disclosure requirements to help consumers make heart-healthy food 
choices. The results of the proposed experimental study will provide 
empirical support for possible policy decisions about the need for such 
disclosures and the appropriate form they should take.
    FDA or its contractor will collect and use information gathered 
from Internet panel samples to evaluate how consumers understand and 
respond to possible disclosure requirements for trans fat content 
claims. The distinctive features of Internet panel and shopping mall 
methodologies for the purpose of the proposed experimental study are 
that they allow for controlled visual presentation of study materials, 
experimental manipulation of study materials, and the random assignment 
of subjects to condition. Experimental manipulation of labels and 
random assignment to condition makes it possible to estimate the 
effects of the various possible disclosure requirements while 
controlling for individual differences. Random assignment ensures that 
mean differences between conditions can be tested using well-known 
techniques such as analysis of variance or regression analysis to yield 
statistically valid estimates of treatment effect size. The proposed 
study will be conducted with a convenience sample drawn from a large, 
national consumer panel with about one million households.
    Participants will be adults, age 18 and older, who are recruited 
for a study about foods and food labels. Each participant will be 
randomly assigned to 1 of the 144 experimental conditions consisting of 
fully crossing 8 disclosure conditions, 3 product types, 3 fatty acid 
profiles and 2 prior knowledge conditions.

[[Page 75555]]

    FDA will use the information from the proposed experimental study 
to evaluate regulatory policy options. The agency often lacks empirical 
data about how consumers understand and respond to statements they 
might see in product labeling. The information gathered from this 
proposed experimental study will be used by the agency to assess likely 
consumer responses to various disclosure requirements for nutrient 
content claims.
    In the Federal Register of February 6, 2006 (71 FR 6076), FDA 
published a 60-day notice requesting public comment on the information 
collection that will take place as part of the experimental study. FDA 
received one letter in response to the notice, containing multiple 
comments.
    (Comment 1) One comment stated that the organization concurs with 
the objectives of the study and believes the information from this 
study will be useful to FDA in developing labeling policy to assist 
consumers with interpretation of trans fat claims in food labeling. 
Another comment suggested that FDA change the labels used to describe 
the three fatty acid profiles in the study (``good profile,'' ``medium 
profile,'' and ``poor profile'') because these descriptors were seen as 
overly negative. The comment recommended alternative language (``low 
profile,'' ``medium profile'' and ``high profile'') as a way to ensure 
that the products are not characterized as ``good foods'' or ``bad 
foods.''
    (Response) This suggestion has been implemented. The terminology 
suggested in the comment adequately conveys the intended profile 
differences.
    (Comment 2) One comment critiqued the draft Full Information 
treatment language. The comment criticized the one-page summary because 
it : (1) Did not identify calories in the discussion of fat as a major 
source of energy and (2) did not relate the calorie contribution of fat 
to that of carbohydrates and protein. The comment also criticized the 
information about sources of trans fat because it omitted mention of 
natural sources of trans fat in the diet, which the comment suggested 
would help ensure factually correct and balanced information about 
sources of trans in the diet. The comment questioned the value of 
stating that trans fat extends shelflife and has desirable taste 
characteristics since many saturated fat sources are relatively shelf 
stable and have desirable taste characteristics.
    (Response) FDA agrees and has revised the Full Information 
treatment to incorporate these concerns. Calories and other sources of 
energy are now mentioned in the introductory passage. Natural sources 
of trans fat are now mentioned and the similarity between trans fat and 
saturated fat in terms of shelflife and taste are now addressed. The 
revised draft will be included in the study pretest and further 
revisions will be made if FDA determines they are needed based upon 
pretest results.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
     Activity         Respondents        per Response        Responses           Response         Total Hours
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Pretest                           40                  1                 40                .25                 10
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Study                          2,880                  1              2,880                .25                720
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Total              .................  .................  .................  .................                730
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: December 8, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21317 Filed 12-14-06; 8:45 am]
BILLING CODE 4160-01-S